A Study for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Brain and/or Spinal Cord Conditions

A Multicenter, Randomized, Double-Blind, Positive-Controlled, Cross-Over, Dose-Escalation Phase II Clinical Trial Evaluating the Efficacy and Safety of HRS-9231 for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06731829

Enrollment

Registered

2024-12-12

Start date

2024-12-31

Completion date

2025-04-30

Last updated

2024-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) Lesions

Brief summary

The purpose of this study is to evaluate the efficacy and safety of HRS-9231 for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI); to explore the effective dose of HRS-9231 for CNS MRI; and to explore the population pharmacokinetic characteristics of HRS-9231 in CNS MRI subjects

Interventions

DRUGHRS-9231

HRS-9231

DRUGGadobutrol

Gadobutrol

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Sign the informed consent form, willing to cooperate with the study, and comply with trial requirements 2. Age ≥18 years, no gender restrictions 3. Known or highly suspected CNS lesions, with imaging showing at least one enhanced lesion 4. Scheduled for CNS contrast-enhanced MRI for clinical needs and agree to complete two contrast-enhanced MRI scans

Exclusion criteria

1. Clinically unstable condition or severe diseases that may affect trial results, such as inability to ensure imaging comparability or reliability of study parameters 2. Moderate to severe renal dysfunction, defined as aGFR \< 60 mL/min 3. Contraindications to MRI, such as metallic implants or claustrophobia 4. History of severe allergies, including drugs, contrast agents, or other allergens 5. Severe liver disease or cardiovascular disease, or related abnormal test results 6. Central nervous system inflammation or recent history of stroke 7. Active infectious diseases, such as HIV, hepatitis B, or syphilis 8. Use of other contrast agents before or after study drug administration, or recent interventional treatments that may affect imaging comparability 9. Pregnancy, breastfeeding, or plans for conception, without effective contraception measures 10. Recent participation in other clinical trials or previous participation in studies involving gadolinium-based contrast agents 11. Other conditions deemed unsuitable by the investigator

Design outcomes

Primary

Measure	Time frame
Calculate the Contrast-to-Noise Ratio (CNR) based on the Signal Intensity (SI) of CNS lesions in MRI images after receiving HRS-9231 or the control drug (Gadobutrol)	1 day procedure

Secondary

Measure	Time frame
Medical applicability of MRI imaging for CNS lesions after receiving HRS-9231 or the control drug (Gadobutrol).	1 day procedure
Number, size, and location of CNS lesions in MRI images after receiving HRS-9231 or the control drug.	1 day procedure
Visualization scores for CNS lesions in MRI images after receiving HRS-9231 or the control drug (Gadobutrol): boundary delineation, internal morphology, and contrast enhancement.	1 day procedure
HRS-9231 plasma concentration and population pharmacokinetic parameters (such as clearance, apparent volume of distribution, etc.).	1 day procedure

Countries

China

Contacts

Primary ContactJunpeng Zhuang

junpeng.zhuang.jz5@hengrui.com+0518-82342973

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026